Multicenter Study Comparing the Artificial Intelligence-Based Navicam Endoscopic Capsule With the Conventional Pillcam Endoscopic Capsule in Small Bowel Pathology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 147
- 试验地点
- 20
- 主要终点
- Concordance correlation coefficient in small bowel exploration (per-patient analysis)
研究概览
简要总结
Since its introduction in 2001, small bowel capsule endoscopy has been pivotal in diagnosing small bowel pathology due to its minimally invasive nature and high diagnostic accuracy. However, the technology has limitations, including prolonged reading times and the need for specialized endoscopists. The Navicam endoscopic capsule, leveraging artificial intelligence (AI) with ProScan™ for automated reading, promises to address these limitations by reducing reading times and enhancing diagnostic efficiency.
This study aims to assess the diagnostic concordance and to compare the efficiency of the AI-based Navicam capsule with the conventional Pillcam SB3 in the exploration of the small bowel.
详细描述
This is a prospective, multicenter, randomized, observational study involving multiple hospitals across Spain. At each site, patients will ingest both the Pillcam SB3 and Navicam capsules in a randomized order. Reading times, transit times, and diagnostic yield will be compared between the two devices. A central reading committee of experienced gastroenterologists will conduct blinded evaluations of both explorations using predefined criteria.
The primary endpoint is the diagnostic concordance between Navicam's AI-driven ProScan™ system and the conventional reading of Pillcam SB3, measured by Cohen's kappa index.
The secondary endpoints include to assess the correlation in lesion detection, video download times, gastric and small bowel transit times, total reading times, and adverse events.
The sample size is 147 patients, accounting for an expected 10% dropout rate, based on previous studies showing a diagnostic concordance kappa index of 0.6.
This study aims to establish that the AI-based Navicam capsule is at least as effective as the conventional Pillcam SB3 in diagnosing small bowel lesions, with potentially reduced reading times, thus enhancing clinical efficiency in small bowel diagnostics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients over 18 years of age with any clinical indication to undergo a small bowel exploration using capsule endoscopy at the participating hospital.
排除标准
- •Patients with known small bowel strictures detected by computed tomography (CT) or magnetic resonance imaging (MRI).
- •Patients with a history of esophagogastric and small bowel surgery (excluding ileocecal resection).
- •Patients with a clinical contraindication for small bowel capsule endoscopy.
- •Hospitalized patients.
- •Patients with pacemaker or Implantable Cardioverter Defibrillator (ICD).
- •Patients scheduled for a MRI within 15 days after capsule endoscopy ingestion.
- •Pregnant or actively breastfeeding patients.
- •Patients with swallowing disorders requiring endoscopic placement of the capsule.
- •Simultaneous participation in another clinical trial using any investigational drug or device.
- •Concurrent life-threatening pathology or condition.
- •Inability to sign the informed consent form.
结局指标
主要结局
Concordance correlation coefficient in small bowel exploration (per-patient analysis)
时间窗: From the start of recording up to 12 hours afterward
To assess the concordance (k agreement) between Navicam (with ProscanTM AI-system) and Pillcam endoscopic capsule device in detecting patients with at least one significant small bowel lesion.
次要结局
- Reading time in minutes(From the start of recording up to 12 hours afterward)
- Adverse events related to Navicam and/or Pillcam SB3(From the start of recording up to 24 hours afterward)
- Transit times in minutes(From the start of recording up to 12 hours afterward)
- Correlation coefficient in lesion detection (per-lesion analysis)(From the start of recording up to 12 hours afterward)